The purpose of the NCI Career Transition Award to Promote
Diversity program is to assist a postdoctoral fellow's transition to
positions of assistant professor or equivalent and initiate a successful
biomedical career as an independent research scientist. To this end, the
Diversity Training Branch (DTB), the Center to Reduce Cancer Health
Disparities (CRCHD) (http://crchd.cancer.gov/)
invites applications from research scientists in postdoctoral positions or
equivalent who are from backgrounds underrepresented in biomedical,
behavioral, clinical, and/or social sciences. This award will provide
"protected time" through salary and research support for 3 years
for recipients to develop and receive support for their initial cancer
research program.

New Date November 20, 2017 per issuance of PAR-18-366. (Original Expiration Date: January 8, 2018)

Due Dates for E.O. 12372

Not Applicable

Required
Application Instructions

It is critical that applicants follow the instructions in
the Career Development Instructions for the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

The
overall goal of the NIH Research Career Development program is to help ensure
that a diverse pool of highly trained scientists is available in appropriate scientific
disciplines to address the Nation's biomedical,
behavioral, and clinical research needs. In addition to this opportunity, NIH
Institutes and Centers (ICs) support a variety of other mentored career
development programs designed to foster the transition of new investigators to
research independence. These other programs may be more suitable for particular
candidates. NIH also supports non-mentored career development programs for
independent investigators.More
information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objective of the NCI Career Transition Award to Promote
Diversity (K22) program is to aid postdoctoral fellows in mentored cancer
research positions to transition to faculty appointments and support them as
they further develop their research skills and establish independent cancer
research programs. To activate the K22 award, the successful candidate must first
secure a tenure-track, full-time assistant professor position or equivalent in
an extramural institution within a year of the receipt of the approval letter.
Once the assistant professor position has been secured, the candidate will
submit updated information about the K22 application with the support of the
sponsoring institution. The sponsoring institution can be the same as the
post-doctoral institution, though it is most likely a different institution
from the original submission of the K22 application. The updated information
of the transition to an assistant professor position at the sponsoring
institution will be evaluated and approved by NCI's CRCHD program staff to
ensure that all programmatic requirements are met prior to the activation of
the K22 award. The details of the requirements for the activation of the K22 award
are described in Part 2, Section IV of this announcement.

The K22 award is intended to facilitate the establishment of
a record of independent research by the candidate in order to sustain or
promote a successful, NIH R01 or equivalent independent research career. The
award prepares qualified individuals for careers that can have a significant
impact on the health-related research needs of the Nation. This one-phase, non-mentored
K22 program is part of a continuing effort to establish a unique pathway for
recruiting and retaining postdoctoral fellows from groups that are
underrepresented in biomedical, behavioral, clinical, and/or social sciences
research (see Section III, Eligible
Individuals) who can conduct independent competitive cancer research programs.
These biomedical research investigations are expected, but not required, to
address problems that are pertinent to cancer health disparities and the
biology, etiology, pathogenesis, prevention, diagnosis, control, and/or
treatment of human cancer.

The NCI K22 award to promote diversity will provide up to 3
years of support for the most promising and exceptionally talented postdoctoral
fellows from populations underrepresented in biomedical, behavioral, clinical,
and/or social sciences. This period of support is to provide the investigator sufficient
time to prepare an application for research grant support (R01 or equivalent).
NIH believes that the creativity and innovation of newly independent
investigators in their early career stages play an integral role in addressing
the Nation’s biomedical, behavioral, and clinical research needs.

Background

Substantial national and local efforts are directed toward a
reduction in cancer morbidity and mortality in the general population. However,
in spite of these efforts, the American Cancer Society estimates that
approximately 1.7 million men and women will be diagnosed with cancer, and
approximately one-third of them will succumb to their cancers in 2014. Past
patterns of cancer incidence and mortality predict that the disproportionate
increase in U.S. cancer incidence and mortality will be experienced by both
underrepresented and underserved populations (http://www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2014/ ). Specifically, cancer rates for stomach, liver, gall bladder, and cervix are
higher in Hispanics than in non-Hispanic whites (http://www.cancer.org/research/cancerfactsfigures/cancerfactsfiguresforhispanicslatinos/).
Stomach and liver cancer incidence and death rates are more than twice as high
in Asian American/Pacific Islanders as in Caucasians, and cancer mortality
rates from prostate, stomach, and cervical cancers among African Americans are
more than twice those in Caucasians.

Specific Research Objectives

A major obstacle to developing a stronger national diverse
cancer research effort has been the lack of significant strategic training
programs for students and scientists from underrepresented groups in cancer
research. Progress in realizing a significant increase in the number of
competitive underrepresented cancer researchers had been disappointing. A
greater involvement of underrepresented candidates, who bring unique cultural
perspectives to the research, is integral to a successful national cancer
research effort towards underserved populations.

The Diversity Training Branch (DTB) of NCI's Center to
Reduce Cancer Health Disparities (CRCHD) (http://crchd.cancer.gov/)
invites applications from postdoctoral fellows or equivalent research
scientists from backgrounds underrepresented in biomedical, behavioral,
clinical, and/or social sciences. This award will provide "protected
time" for recipients to develop and receive support for their initial
cancer research program.

Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.

Application
Types Allowed

New
Resubmission
The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.

Award Budget

Award budgets are composed of salary and other
program-related expenses, as described below.

Award Project Period

The total project period may not exceed 3 years.

Other Award Budget
Information

Salary

NCI will contribute up to $100,000 per year
toward the salary of the career award recipient. Further guidance on
budgeting for career development salaries is provided in the SF424 (R&R)
Application Guide.

NCI will contribute $ 50,000 per year toward the research
development costs of the award recipient, which must be justified and
consistent with the stage of development of the candidate and the proportion
of time to be spent in research or career development activities.

Salary for advisors, consultants, collaborators,
secretarial and administrative assistants, etc. is not allowed.

Indirect Costs

Indirect Costs (also known as
Facilities & Administrative [F&A] Costs) are reimbursed at 8% of
modified total direct costs.

NIH grant policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants must have an active DUNS number and SAM registration in order to
complete the eRA Commons registration. Organizations can register with the eRA
Commons as they are working through their SAM or Grants.gov registration. eRA
Commons requires organizations to identify at least one Signing Official (SO)
and at least one Program Director/Principal Investigator (PD/PI) account in
order to submit an application.

Grants.gov – Applicants must have an active DUNS number and SAM registration in order to
complete the Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing
Official, they must have two distinct eRA Commons accounts, one for each role.
Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any candidate with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a
non-citizen national of the United States or have been lawfully admitted for
permanent residence (i.e., possess a currently valid Permanent Resident Card
USCIS Form I-551, or other legal verification of such status

EnhancingDiversity

The overarching goal of this FOA is to enhance the pool of
independent cancer research investigators from backgrounds underrepresented in
the biomedical, clinical, behavioral, and social sciences such as: individuals
from underrepresented and underserved populations, individuals with
disabilities, and individuals from socially, culturally, economically, or
educationally disadvantaged backgrounds that have inhibited their ability to
pursue a career in health-related research (NOT-OD-15-053).
The NIH is particularly interested in encouraging the recruitment and retention
of the following classes of candidates:

1. Individuals who come
from a family with an annual income below established low-income thresholds.
These thresholds are based on family size, published by the U.S. Bureau of the
Census; adjusted annually for changes in the Consumer Price Index; and adjusted
by the Secretary for use in all health professions programs. The Secretary
periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml.

2. Individuals who come
from an educational environment such as that found in certain rural or
inner-city environments that has demonstrably and directly inhibited the
individual from obtaining the knowledge, skills, and abilities necessary to
develop and participate in a research career.

The disadvantaged
background category (C1 and C2) is applicable to programs focused on high
school and undergraduate candidates. Therefore, given the purpose of this
funding opportunity announcement, this category is ineligible for support.

Additional
Eligibility Criteria

Postdoctoral
Investigators:

The intent of the NCI K22 award to promote diversity program
is to support cancer research scientists in their postdoctoral positions
transition to independent faculty positions, and conduct biomedical research as
an independent scientist at an extramural sponsoring institution/organization
to which the individual has been recruited. This is the continuation of
NCI program aimed at facilitating the transition of underrepresented new
investigators from mentored research positions into non-mentored investigators
who can compete successfully for NIH-supported research grants such as R01 or
equivalent. These underrepresented new investigators will not transition into
established investigators without the support provided by the K22 diversity
awards. Therefore, at the time of the initial application submission,
candidates for this award must: (1) have earned a terminal clinical or research
doctorate (including PhD, MD, DO, DC, ND, DDS, DMD, DVM, ScD, DNS, PharmD, or
equivalent doctoral degree) or a combined research doctorate/clinical degree;
(2) have at least 2 years of postdoctoral training in cancer research at the
time of submission of the initial application (e.g., postdoctoral fellow,
postdoctoral associate, clinical fellow, clinical associate or equivalent); and
(3) have no more than a total of 8 years of mentored research training
experience after the terminal clinical or research doctorate at the time of
initial application.

Clinicians: Clinicians (including those with M.D., D.D.S, D.V.M. and other
licensed professionals) in positions not designated as postdoctoral positions:
Following clinical training or fellowship training periods, clinicians often
obtain a clinical faculty position that denotes independence in clinical
responsibilities but not in research. Time spent in clinical training is not
counted for the 8-year postdoctoral research experience limit; a clinical
faculty member who does not hold an independent research faculty position may
be eligible for this K22 award, and should contact the NCI Program Director listed
in Section VII for guidance. Clinicians in such positions are encouraged to
obtain confirmation of their eligibility before they begin to prepare their
applications. Such individuals may also wish to consider other career awards (see K Kiosk)
available for junior faculty development.

Other
Candidates: Some institutions appoint postdoctoral fellows in
positions with other titles (e.g., research associate, instructor, or
equivalent) but they are still in mentored training positions. Candidates in
such positions are encouraged to obtain confirmation of their eligibility
before they begin to prepare their applications. It is incumbent upon the
candidate to provide evidence that he/she is in a position that is equivalent
to that of a post-doctoral scientist.

Investigators trained in Mathematics, Physical Sciences
and/or Engineering may want to consider re-orienting to cancer-focused research
careers. Such investigators should have some prior training in cancer research
to be competitive for this non-mentored K22 grant.

NIH
Intramural Candidates:Mentored, non-independent investigators in NIH intramural
laboratories and other eligible agencies of the Federal Government are eligible
to apply for the NCI K22 award.

Individuals affiliated with an NIH Intramural Laboratory may
apply (specific
information is available for intramural candidates on the Electronic
Submission Intranet – link available only to users internal to NIH).

Individuals not affiliated with an organization may apply (specific information is available for unaffiliated candidates).

Individuals
are NOT eligible for the NCI K22 to Promote Diversity if they:

Have currently or previously held an independent research faculty
or tenure-track faculty position, or its equivalent, in academia, industry or
elsewhere; or

Have less than 2 years of postdoctoral training in cancer
research at the time of initial application; or

Have more than a total of 8 years of mentored, non-independent
research training after the terminal clinical or research doctorate at the time
of initial application; or

Have an application pending for any other PHS career development
award, including a Pathway to Independence Award (K99/R00); or

Have currently or have previously held another NIH career
development award or (e.g., K01, K07, K08, K18, K22, K23, K25, K99, K99/R00);
or

Have been an independent principal investigator on an NIH
research project grant (e.g., R01, R21; P01) or a subproject leader on a
Program Project (P01) or Center Grant (P50), or other peer reviewed NIH or a
non-NIH research grants over $100,000 direct costs per year (e.g. P01, U19) or equivalent
to these grants/awards; or

Have currently or have previously held other peer-reviewed NIH
(except R03) or non-NIH research grants over $100,000 in direct costs per year.

Individuals are eligible for a K22 award if they have been,
or currently are, the PD/PI of an NIH R03 or R21 grant or a PHS or non-Federal
award that duplicates the specific aims or research goals of an R03 or R21
grant. Individuals are NOT eligible to apply if they have pending an
application for any other PHS career development award, an NIH
institute-specific K22, or a Pathway to Independence Award (K99/R00).

The following is provided as an aid to distinguish
independent from non-independent positions.

However, it is not sufficient merely to cite one or more of
the following items to document eligibility.

Evidence for
non-independence may include:

The candidate’s research is entirely funded by another
investigator’s grants.

The candidate’s research is conducted entirely in another
investigator’s assigned space.

According to institutional policy, the candidate cannot hire
postdoctoral fellows or technical staff or be the responsible supervisor of
graduate students.

According to institutional policy, the candidate is not allowed
to submit an application as the PD/PI of an NIH research grant application
(e.g., R01).

The candidate lacks other rights and privileges of faculty, such
as attendance at faculty meetings.

Conversely,
evidence for independence, and therefore lack of eligibility, includes:

The candidate has a full-time faculty position.

The candidate received a start-up package for support of his/her
independent research.

The candidate has research space dedicated to his/her own
research.

The candidate may attend faculty meetings, be the responsible
supervisor for graduate students, and/or hire technical support or postdoctoral
fellows.

The candidate is eligible to apply for independent research
funding as the PD/PI of an NIH research grant.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct, and each is from a
different candidate.

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. An individual may not have two or
more competing NIH career development applications pending review concurrently.
In addition, NIH will not accept:

A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.

A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another
application pending appeal of initial peer review (see NOT-OD-11-101).

Candidates may submit research project grant (RPG)
applications concurrently with the K application. However, any concurrent RPG
application may not have substantial scientific and/or budgetary overlap with the
career award application. K award recipients are encouraged to obtain funding
from NIH or other Federal sources either as a PD/PI on a competing research
grant award or cooperative agreement, or as project leader on a competing multi-project
award as described in NOT-OD-08-065.

Level of Effort

At the time of award, the candidate must have a “full-time”
appointment at the academic institution. Candidates are required to commit a
minimum of 75% of full-time professional effort (i.e., a minimum of 9
person-months) to their career development and research training during the non-mentored
award. Candidates may engage in other duties as part of the remaining 25% of
their full-time professional effort not covered by this award, as long as such
duties do not interfere with or detract from the proposed career development
program.

Candidates who have VA appointments may not consider part of
the VA effort toward satisfying the full time requirement at the applicant
institution. Candidates with VA appointments should contact the staff person in
the relevant Institute or Center prior to preparing an application to discuss
their eligibility. Under certain circumstances, an awardee may submit a written
request to the awarding component requesting a reduction in minimum required
percent effort, which will be considered on a case-by-case basis. Details on
this policy are provided in NOT-OD-09-036.

Institutional Environment

The applicant institution must have a strong,
well-established record of research and career development activities and
faculty qualified in biomedical, behavioral, or clinical research to
collaborate with the applicant.

Section IV. Application
and Submission Information

1. Requesting an
Application Package

Buttons to access the online ASSIST system or to download
application forms are available in Part
1 of this FOA. See your administrative office for instructions if you plan
to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the Career Development Instructions for the SF424
(R&R) Application Guide, including Supplemental
Grant Application Instructions except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for review.

All page limitations described in the SF424 (R&R)
Application Guide and the Table of
Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in
the SF 424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Project Summary/Abstract

Include a description of your
current research and the research you propose to continue in the independent K22
award.

Other
Attachments:

A letter certifying that the candidate belongs to
category A or B, as described in Section III.1 must be submitted by the
applicant Institution. Name the PDF formatted letter
‘EligibilityCertification.pdf’.

SF424(R&R) Senior/Key Person Profile Expanded

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must
be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed

PHS 398 Career Development Award Supplemental Form

The PHS 398 Career Development Award Supplemental Form is
comprised of the following sections:

Candidate

Research Plan

Other Candidate Information

Mentor, Co-Mentor, Consultant, Collaborators

Environment & Institutional Commitment to the Candidate

Human Subjects Sections

Other Research Plan Sections

Appendix

All instructions in the SF424 (R&R) Application Guide must
be followed, with the following additional instructions:

Candidate Section

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Candidate
Information and Goals for Career Development

Candidate’s
Background

Describe the candidate's commitment to a career in a biomedical,
behavioral, or clinical research field relevant to the mission of NCI.

Describe prior training and research efforts, and how they relate
to the objectives and long-term career plans of the candidate.

Describe the candidate’s research efforts to this point in
his/her research career, including any publications, prior research interests
and experience.

Provide evidence of the candidate’s potential to develop into an
independent research investigator. Usually this is evident from publications,
prior research interests and experience, and letters of reference.

Career
Goals and Objectives

Describe a systematic plan: (1) that shows a logical progression
from prior research and training experiences to the research and career
development experiences that will occur during the K22 award period and then to
independent investigator status; (2) that justifies the need for further
career development to become an independent investigator; (3) that utilizes
the relevant research and educational resources of the institution; and (4) that
describes the candidate's current, as well as long-term, research and career
objectives including any didactic component.

Candidate’s
Plan for Career Development/Training Activities During Award Period

The candidate is responsible for the preparation of the career
development plan. A timeline, including publication and R01 submission plans, is
often helpful, and is strongly encouraged.

A systematic plan should be presented for obtaining biomedical,
behavioral, or clinical science background, research experience, and career development
activities necessary to launch the stated independent research career. Describe
current activities and how they relate to the candidate’s career development
plans and career goals. Describe proposed activities, e.g., those that will
lead to new and/or enhanced research skills and knowledge, as well as related
skills such as grant-writing, communication, leadership, and laboratory
management.

The career development plan must be tailored to the needs of the
individual candidate with the ultimate goal of achieving independence as a
researcher.

The candidate must justify the need for the K22 award and must
provide a convincing case that the proposed period of support (3 years) will
substantially enhance his/her career and allow the pursuit of a novel or
promising approach to a particular cancer research problem.

The career development plan should describe the steps that will
be undertaken to apply for NIH or other independent research project grant
support (R01 or equivalent) prior to the end of the second year of support.

Although not required, an advisory committee may be formed to
monitor the candidate’s progress during the career development program. If the
exact composition of an advisory committee is not known at the time of
submission, general roles and contributions of future committee members can be
discussed.

Research Plan Section

All instructions in the SF424 (R&R) Application
Guide must be followed, with the following additional instructions:

Research
Strategy

A sound research project that is consistent with the candidate’s
level of research development and objectives of his/her career development plan
must be provided.

The research description should demonstrate not only the quality
of the candidate’s research thus far but also the novelty, significance,
creativity and approach, as well as the ability of the candidate to carry out
the research.

Training
in the Responsible Conduct of Research

All applications must include a plan to fulfill NIH requirements
for instruction in the Responsible Conduct of Research (RCR). See SF424
(R&R) Application Guide for instructions.

Consultant, Collaborators Section

All instructions in the SF424 (R&R) Application
Guide must be followed, with the following additional instructions:

Letters of Support from Collaborators,
Contributors and Consultants

Signed statements must be provided by all collaborators and/or
consultants confirming their participation in the project and describing their
specific roles. Collaborators and consultants generally do not need to provide
their biographical sketches. However, information should be provided clearly
documenting the appropriate expertise in the proposed areas of
consulting/collaboration. Collaborators/consultants are generally not directly
involved in the development of the career of the candidate as an independent
investigator.

Environmental and Institutional
Commitment to the Candidate

All instructions in the SF424 (R&R) Application
Guide must be followed, with the following additional instructions:

Description
of Institutional Environment

The sponsoring institution must document a strong,
well-established research and career development program related to the
candidate's area of interest, including a high-quality research environment
with key faculty members and other investigators capable of productive
collaboration with the candidate.

Describe the sponsoring institution’s scientific environment
including the resources and facilities that will be available to the candidate.

Institutional
Commitment to the Candidate’s Research Career Development

The sponsoring/submitting institution must provide a statement of
commitment to meeting the requirements of this award

Appendix

Do not use the Appendix to circumvent page limits.
Follow all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions
for completing PHS Inclusion Enrollment Report as described in the SF424
(R&R) Application Guide.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide
must be followed.

Letters of Reference

Candidates must carefully follow the SF424 (R&R)
Application Guide, including the time period for when letters of reference
will be accepted. Applications lacking the appropriate required reference
letters will not be reviewed. This is a separate process from submitting an
application electronically. Reference letters are submitted directly through
the eRA
Commons Submit Referee Information link and not through Grants.gov.

3. Unique Entity Identifier
and System for Award Management (SAM)

See Part 1.
Section III.1 for information regarding the requirement for obtaining a unique
entity identifier and for completing and maintaining active registrations in
System for Award Management (SAM), NATO Commercial and Government Entity
(NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission. When
a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies) using ASSIST or other electronic submission
systems. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants administration.
NIH and Grants.gov systems check the application against many of the
application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the
application due date. and time. If a Changed/Corrected application is
submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the
NIH Policy on Late Application Submission.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues. For assistance with application
submission contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in
the Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS
number it provides on the application is the same number used in the
organization’s profile in the eRA Commons and for the System for Award
Management (SAM). Additional information may be found in the SF424 (R&R)
Application Guide.

Upon receipt, applications will be evaluated for
completeness and compliance with application instructions by the Center for
Scientific Review, NIH. Applications that are incomplete or non-compliant will
not be reviewed.

In order to expedite review, applicants are requested to
notify the NCI Referral Office by email at ncirefof@dea.nci.nih.gov when the
application has been submitted. Please include the FOA number and title, PD/PI
name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers should provide their assessment of the likelihood that
the proposed career development and research plan will enhance the candidate’s
potential for a productive, independent scientific research career in a
health-related field, taking into consideration the criteria below in
determining the overall impact score.

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An application
does not need to be strong in all categories to be judged likely to have major
scientific impact.

Candidate

Does the candidate have the potential for becoming a successful
independent investigator who will contribute significantly to a chosen health-related
research field?

Will the current research experiences prepare the candidate to successfully
implement the proposed research project?

What is the scientific productivity during the postdoctoral
period of cancer research training in terms of research experience(s), didactic
experiences, and other experiences (e.g., special skills, perspectives,
techniques), and has it enhanced the candidate's ability to pursue an
independent cancer research career?

Is the candidate committed to an independent research career that
will be focused on problems clearly relevant to cancer?

Does the candidate have the potential ability to successfully
manage an independent cancer research project?

Do the letters of reference from at least three established
scientists address the candidate's potential for becoming an independent cancer
research investigator?

Is the candidate’s academic, clinical (if relevant), and research
record of high quality?

Is there evidence of the candidate’s commitment to meeting the
program objectives to become an independent investigator?

Career
Development Plan/Career Goals and Objectives

Are the content, scope, phasing, and duration of the career
development plan appropriate when considered in the context of prior
training/research experience and the stated career development and research
objectives for achieving research independence?

Are there adequate plans for monitoring and evaluating the
candidate’s research and career development progress?

Research Plan

Is there a strong scientific
premise for the project?

Has the candidate
presented strategies to ensure a robust and unbiased approach, as appropriate
for the work proposed?

Has the candidate presented adequate plans to
address relevant biological variables, such as sex, for studies in vertebrate
animals or human subjects?

Is the proposed research project appropriate for the candidate's
stage of research development and as a vehicle for development of the research
skills described in the career development plan?

Is the proposed research relevant to stated career objectives?

Are the scientific and technical merits of the research question,
design, and methodology appropriate in the context of prior training and
experience?

To what extent is the proposed research likely to foster the career
of the candidate as an independent investigator in cancer research?

Consultant(s),
Collaborator(s)

Is adequate information provided that clearly documents expertise
in the proposed area(s) of consulting/collaboration?

Have the proposed consultant(s) and collaborator(s) provided
evidence of commitment to the candidate and the candidate’s project?

Do the proposed consultant(s)/collaborator(s) provide the
required expertise for successful conduct of the research project?

Environment
& Institutional Commitment to the Candidate

Are the research facilities, resources and training
opportunities, including faculty capable of productive collaboration with the
candidate adequate and appropriate?

Is there clear commitment of the sponsoring institution to ensure
that the required effort of the candidate will be devoted directly to the
research training, career development, and research activities described in the
proposed career development and research plans?

Is there strong institutional commitment to fostering the career
development of the candidate?

Are there unique features of the scientific environment that
benefit the proposed research; e.g., useful collaborative arrangements or
subject populations?

Is the environment of high quality and relevance for scientific
and professional development of the candidate?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections
for Human Subjects

For research that involves human
subjects but does not involve one of the six categories of research that are
exempt under 45 CFR Part 46, the committee will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3)
potential benefits to the subjects and others, (4) importance of the knowledge
to be gained, and (5) data and safety monitoring for clinical trials.

For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: (1)
the justification for the exemption, (2) human subjects involvement and
characteristics, and (3) sources of materials. For additional information on
review of the Human Subjects section, please refer to the Guidelines for the Review of Human
Subjects.

Inclusion
of Women, Minorities, and Children

When the proposed project involves
human subjects and/or NIH-defined clinical research, the committee will
evaluate the proposed plans for the inclusion (or exclusion) of individuals on
the basis of sex/gender, race, and ethnicity, as well as the inclusion (or
exclusion) of children to determine if it is justified in terms of the
scientific goals and research strategy proposed. For additional information on
review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion
in Clinical Research.

Vertebrate
Animals

The committee
will evaluate the involvement of live vertebrate animals as part of the
scientific assessment according to the following criteria: (1) description of
proposed procedures involving animals, including species, strains, ages, sex,
and total number to be used; (2) justifications for the use of animals versus
alternative models and for the appropriateness of the species proposed; (3)
interventions to minimize discomfort, distress, pain and injury; and (4)
justification for euthanasia method if NOT consistent with the AVMA Guidelines
for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as
they would any other application proposing the use of vertebrate animals. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.

Resubmissions

For Resubmissions, the committee
will evaluate the application as now presented, taking into consideration the
responses to comments from the previous scientific review group and changes
made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Training in the
Responsible Conduct of Research

All applications for support under this FOA must
include a plan to fulfill NIH requirements for instruction in the Responsible
Conduct of Research (RCR). Taking into account the level of experience of the
applicant, including any prior instruction or participation in RCR as appropriate
for the applicant’s career stage, the reviewers will evaluate the adequacy of
the proposed RCR training in relation to the following five required
components: 1) Format - the required format of instruction, i.e.,
face-to-face lectures, coursework, and/or real-time discussion groups (a plan
with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data
management, human subjects and animal use, laboratory safety, research
misconduct, research ethics; 3) Faculty Participation - the role of the
mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration
of Instruction - the number of contact hours of instruction (at least eight
contact hours are required); and 5) Frequency of Instruction –instruction
must occur during each career stage and at least once every four years. Plans
and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and
the summary statement will provide the consensus of the review committee. See
also: NOT-OD-10-019.

Select Agent
Research

Reviewers will assess the information provided in
this section of the application, including (1) the Select Agent(s) to be used
in the proposed research, (2) the registration status of all entities where
Select Agent(s) will be used, (3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and (4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

For projects involving key
biological and/or chemical resources, reviewers will comment on the brief plans
proposed for identifying and ensuring the validity of those resources.

Budget and
Period of Support

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications. Following
initial peer review, recommended applications will receive a second level of
review by the appropriate national Advisory Council or Board. The following
will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as described
in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be
subject to terms and conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website.

The National Cancer Institute will transmit to all successful
candidates an approval letter that will include the terms and conditions of the
K22 award.

Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person’s race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator’s scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols
that target or exclude certain populations are warranted where
nondiscriminatory justifications establish that such criteria are appropriate
with respect to the health or safety of the subjects, the scientific study
design, or the purpose of the research.

In accordance with the statutory provisions contained in
Section 872 of the Duncan Hunter National Defense Authorization Act of
Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to
theFederal Awardee Performance and Integrity Information System
(FAPIIS) requirements. FAPIIS requires Federal award making officials to
review and consider information about an applicant in the designated integrity
and performance system (currently FAPIIS) prior to making an award. An
applicant, at its option, may review information in the designated integrity
and performance systems accessible through FAPIIS and comment on any
information about itself that a Federal agency previously entered and is
currently in FAPIIS. The Federal awarding agency will consider any comments by
the applicant, in addition to other information in FAPIIS, in making a
judgement about the applicant’s integrity, business ethics, and record of
performance under Federal awards when completing the review of risk posed by
applicants as described in 45 CFR Part 75.205 “Federal awarding agency review
of risk posed by applicants.” This provision will apply to all NIH grants and
cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply
to NIH grant programs, please contact the Scientific/Research Contact that is
identified in Section VII under Agency Contacts of this FOA. HHS provides
general guidance to recipients of FFA on meeting their legal obligation to take
reasonable steps to provide meaningful access to their programs by persons with
limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html.
The HHS Office for Civil Rights also provides guidance on complying with civil
rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html;
and http://www.hhs.gov/ocr/civilrights/understanding/index.html.
Recipients of FFA also have specific legal obligations for serving qualified
individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
Please contact the HHS Office for Civil Rights for more information about
obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care,
including long-term services and supports, for vulnerable populations. For
further guidance on providing culturally and linguistically appropriate
services, recipients should review the National Standards for Culturally and
Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

This K22 will provide funding for one stage of non-mentored
research. The candidate submits a K22 application from the institution where he/she
currently pursues either advanced post-doctoral research training or a
mentored non-independent research training. The application will be peer
reviewed and assigned an overall impact score. Successful candidates (i.e.
whose application has been selected for funding) will receive a Letter of
Intent to Commit Funds from NCI that will include the terms and conditions to
issue/activate the K22 award; the award will not actually be issued with this
Letter of Intent to Commit Funds. In order to issue/activate the K22 award, the
candidate will need to first secure a tenure-track faculty position in an
extramural institution that is not a part of the federal government, no later
than 12 months of the receipt of the Letter of Intent to Commit Funds. Once the
faculty position has been secured, the candidate will submit updated
information about the K22 application and transition to a tenure-track faculty
position through the sponsoring institution. The updated information about the
transition to a tenure-track faculty position at the sponsoring institution
will be evaluated by NCI staff to ensure that all programmatic requirements are
met prior to the issuance/activation of the K22 award.

The sponsoring institution must demonstrate a commitment to
the candidate by providing a minimum of nine person-months (75% full time
professional effort) protected research time, space and resources needed to
conduct the proposed research project and appropriate scientific mentoring. A
plan for career development that will lead to research independence and the
ability to successfully compete for research support is essential.

The sponsoring institution will submit the transition
application on behalf of the Candidate using form PHS 2590,
which should provide details of the specific aims of the Research Plan and on
the pursuit of identified career and career development goals. Future goals for
the research project and for further career development should also be
indicated.

Form PHS 2590 must include the following:

A description of the proposed research.

A description of the institutional environment, including:
research facilities and the availability of appropriate educational
opportunities, including collaborating faculty, when necessary; quality and
relevance of the environment for scientific and professional development of the
candidate.

Information about the sponsoring institution’s commitment to the
candidate and to the candidate’s scientific independence, including: commitment
to ensuring that the candidate’s effort required by the K22 program will be
devoted directly to the research and career development activities described in
the proposed career development and research plans; institutional commitment to
fostering the career development of the candidate.

Position Description: the institution should provide a detailed
description of the candidate’s position, responsibilities, and duties. The
institution’s tenure-track policy should be defined or a description should be
provided of the equivalent arrangements for institutions without a formal
tenure-track.

Budget in detail, including justification for all requested
funds:

List the name, role on project and percent effort for all project
personnel (salaried and unsalaried) and provide a narrative justification for
each person;

Identify all consultants by name and organization affiliation and
describe the services to be performed;

Provide a narrative justification for any major budget items,
other than personnel, that are requested for the conduct of the project;

Describe specific resources committed by the sponsoring
institution to support the Candidate’s research.

3. Reporting

When multiple years are
involved, awardees will be required to submit the Research Performance Progress
Report (RPPR) annually and financial statements as required in the NIH Grants
Policy Statement. The Supplemental Instructions for Individual Career
Development (K) RPPRs must be followed.

A final progress report,
invention statement, and the expenditure data portion of the Federal Financial
Report are required for closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of
performance of a Federal award, must report and maintain the currency of
information reported in the System for Award Management (SAM) about civil,
criminal, and administrative proceedings in connection with the award or
performance of a Federal award that reached final disposition within the most
recent five-year period. The recipient must also make semiannual
disclosures regarding such proceedings. Proceedings information will be
made publicly available in the designated integrity and performance system
(currently FAPIIS). This is a statutory requirement under section 872 of
Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010
of Public Law 111-212, all information posted in the designated integrity and
performance system on or after April 15, 2011, except past performance reviews
required for Federal procurement contracts, will be publicly available. Full
reporting requirements and procedures are found in Appendix XII to 45 CFR Part
75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

4. Evaluation

In carrying out its stewardship of human resource-related
programs, the NIH may request information essential to an assessment of the
effectiveness of this program from databases and from participants themselves. Participants
may be contacted after the completion of this award for periodic updates on
various aspects of their employment history, publications, support from
research grants or contracts, honors and awards, professional activities, and
other information helpful in evaluating the impact of the program.

Within ten years of making awards under this program, NIH
will assess the program’s overall outcomes, gauge its effectiveness in
enhancing diversity, and consider whether there is a continuing need for the
program. Upon the completion of this evaluation, NIH will determine
whether to (a) continue the program as currently configured, (b) continue the
program with modifications, or (c) discontinue the program.

The overall evaluation of the program will be based on
metrics that will include, but are not limited to, the following:

Subsequent participation in research or employment that impacts research

Authorship of scientific publications in a cancer research field

Subsequent independent research grant support from NIH or another
source

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.